Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
September 6, 2015 updated by: SoberLink, LLC
This is an exempt, retrospective study of a limited set of information obtained from patients' medical records at 10 to 12 substance abuse treatment programs combined with alcohol breath analyzer results during up to 3 years of aftercare monitoring.
The study objectives are 1) to compare the compliance rates and likelihood of achieving sustained sobriety for aftercare patients in mandated (eg, impaired professionals) versus non-mandated monitoring programs and 2) identify components within patients' monitoring agreements that are significantly correlated with positive outcomes.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Juno Beach, Florida, United States, 33408
- Ed Pigott
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Alcohol abusers enrolled into an aftercare program following residential treatment for alcohol abuse
Description
Inclusion Criteria:
- Adults with a diagnosis of alcohol abuse enrolled into an aftercare program following residential treatment
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Mandated impaired professionals
Physicians and other licensed healthcare professionals in mandated monitoring programs by State licensing boards due to Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment.
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Soberlink Alcohol Breath Analyzer System combined with aftercare services
|
|
Non-mandated adults
A general population of adults in aftercare following residential treatment for Alcohol Use Disorder who are treated with Soberlink combined with aftercare services following residential treatment.
|
Soberlink Alcohol Breath Analyzer System combined with aftercare services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compliance rates (negative versus positive versus false positive alcohol test findings)
Time Frame: Test administered 2 to 4 times per day for up to 3 years
|
Test administered 2 to 4 times per day for up to 3 years
|
|
Response rates: defined as use of device when prompted-will include several values such as missed, late, excused
Time Frame: Test administered 2 to 4 times per day for up to 3 years
|
Test administered 2 to 4 times per day for up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ed Pigott, Ph.D., Mr. Pigott
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
November 1, 2015
Study Completion (Anticipated)
November 1, 2015
Study Registration Dates
First Submitted
September 4, 2015
First Submitted That Met QC Criteria
September 6, 2015
First Posted (Estimate)
September 9, 2015
Study Record Updates
Last Update Posted (Estimate)
September 9, 2015
Last Update Submitted That Met QC Criteria
September 6, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (Coordenação de Aperfeiçoamento de Pessoal de Nível Superior - Brasil (CAPES))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.